Immuno-Products Industries: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Immuno-Products Industries” (first 1981, latest 1985), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 18 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| GMS | Anti-Human Globulin, Fta-Abs Test | 2 | 2 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | 2 |
| DBE | Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| DHC | System, Test, Systemic Lupus Erythematosus | 1 | 1 |
| JZO | System, Test, Thyroid Autoantibody | 1 | 1 |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | 1 | 1 |
Review panels
- Immunology (10)
- Microbiology (2)
Most recent Immuno-Products Industries 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853122 | IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED | GMS | 1985-09-19 | 56 |
| K852231 | ANA/LITE-HEP-2 TEST SYSTEM | LJM | 1985-07-10 | 49 |
| K852230 | ANA/LITE-RL TEST SYSTEM | LJM | 1985-07-10 | 49 |
| K843613 | FLUORESCENT TREPONEMEL ANTIBODY-ABSORB | GMS | 1984-10-31 | 51 |
| K831054 | ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB | DHN | 1983-04-27 | 26 |
| K830652 | ANTI N DNA-HCP | KTL | 1983-03-24 | 17 |
| K821576 | ANTINUCLEAR ANTIBODY SCREEN FLOURESC | DBL | 1982-06-10 | 13 |
| K810985 | ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT | DHN | 1981-05-01 | 18 |
| K810984 | ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST | DBM | 1981-05-01 | 18 |
| K810983 | ANTISMOOTH MUSCLE ANTIBODY TEST SYS | DBE | 1981-05-01 | 18 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Immuno-Products Industries.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Immuno-Products Industries?
FDA lists 12 510(k) clearances under the applicant name “Immuno-Products Industries” (first 1981, latest 1985), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Immuno-Products Industries?
The median time from FDA receipt to decision across 510(k)s cleared under the name Immuno-Products Industries is 18 days.
Which FDA product codes appear under Immuno-Products Industries?
The most frequent FDA product codes under this applicant name are DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 2); GMS (Anti-Human Globulin, Fta-Abs Test, 2); LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 2).
Next steps
- See all 12 Immuno-Products Industries clearances with predicates and recalls
- Run predicate analysis for product code DHN, Immuno-Products Industries's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.